P4583Effect of permanent right internal mammary artery occlusion on right coronary artery collateral function. a randomized controlled trial

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M R Bigler ◽  
M Stoller ◽  
C Tschannen ◽  
R Grossenbacher ◽  
C Seiler
Keyword(s):  
Coronary Artery ◽  
Angina Pectoris ◽  
Right Coronary Artery ◽  
Study Endpoint ◽  
Control Group ◽  
Sham Control ◽  
Randomized Controlled ◽  
Internal Mammary ◽  
Sham Control Group

Abstract Background Extracardiac coronary artery supply via the pericardiophrenic branch of the internal mammary arteries (IMA) has been well documented anatomically. Recently, a proof-of-concept study has found functional relevance of these anastomoses in patients with coronary artery disease (CAD) during a brief right coronary artery (RCA) occlusion. Purpose The aim of the present randomized controlled, single-blind trial was to investigate the effect of permanent right IMA (RIMA) occlusion on RCA collateral flow index (CFI) and on the occurrence of angina pectoris. We hypothesized that the change in RCA CFI from baseline to follow-up examination is higher in the group of patients with than without permanent RIMA occlusion. Methods One hundred patients with CAD were randomly allocated (1:1) to permanent RIMA device occlusion at baseline or to no RIMA occlusion (sham control group). The primary study endpoint was CFI change in the RCA from baseline to the 6-week follow-up examination. CFI is the ratio between mean coronary occlusive and aortic pressure both subtracted by central venous pressure as obtained during a 1-minute proximal RCA balloon occlusion. RCA CFI was measured at baseline before RIMA occlusion or the sham procedure and at the follow-up invasive exam. At the end of the same occlusion, occurrence of angina pectoris was assessed. Percutaneous coronary intervention (PCI) of the RCA was deferred until after follow-up RCA CFI measurement. Results There were 51 patients in the RIMA occlusion (verum) group and 49 patients in the sham control group. PCI in the left coronary territory was performed at baseline for clinical reasons in 27 patients of the verum group and in 25 patients of the sham control group. There were no differences in clinical characteristics at baseline between the groups (age 68±12 years, 88 men). RCA CFI change during the 6 weeks of follow-up was equal to +0.028±0.077 in the verum group and −0.026±0.079 in the sham control group (p=0.0017). Angina pectoris during CFI measurement had disappeared at follow-up exam in 30% of the verum group and in 2% of the sham control group (p=0.0013). Conclusions Right coronary collateral function is augmented 6 weeks after permanent RIMA occlusion when compared to sham treatment. This manifests as less frequent angina pectoris during myocardial ischemia among patients with RIMA occlusion. Acknowledgement/Funding This study was supported by a grant from the Swiss National Science Foundation for Research (grant #32003B_163256/1 to CS).

scholarly journals Electro-acupuncture for central obesity: randomized, patient-assessor blinded, sham-controlled clinical trial protocol

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Linda L. D. Zhong ◽  
Xingyao Wu ◽  
Tsz Fung Lam ◽  
Ying Ping Wong ◽  
Peihua Cao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Central Obesity ◽  
Medical Condition ◽  
The Body ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Hip Circumference ◽  
Sham Control ◽  
Sham Control Group

Abstract Background Obesity is a common medical condition. Among all the classifications of obesity, central obesity is considered to be a significant threat on the health of individuals. Scientific researches have demonstrated that the accumulation of intra-abdominal fat is associated with higher metabolic and cardiovascular disease risks independently from Body Mass Index (BMI). Our previous research found that the combination of electro-acupuncture and auricular acupressure could significantly reduce the body weight and the BMI compared to sham control group. Methods/design This is a patient-assessor blinded, randomized, sham-controlled clinical trial on electro-acupuncture for central obesity. One hundred sixty-eight participants with central obesity will be randomly assigned to two groups, which are the acupuncture group and the sham control group. The whole study duration will be 8-week treatment plus 8-week follow up. The primary outcome is the change in waist circumference before and after the treatment. The secondary outcomes include the changes in hip circumference, waist-to-hip circumference ratio, BMI and body fat percentage during the treatment and follow-up. Conclusion The trial will evaluate the efficacy and safety of electro-acupuncture for central obesity compared with sham acupuncture. The study may provide the solid evidence of electro-acupuncture on central obesity in Hong Kong. Trial registration ClinicalTrials.gov Identifier: NCT03815253,Registered 24 Jan 2019.

scholarly journals Effectiveness of Text Messaging as an Incentive to Maintain Physical Activity after Cardiac Rehabilitation: A Randomized Controlled Pilot Study

2021 ◽  
Vol 18 (12) ◽  
pp. 6645
Author(s):  
Giulia Foccardi ◽  
Marco Vecchiato ◽  
Daniel Neunhaeuserer ◽  
Michele Mezzaro ◽  
Giulia Quinto ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cardiac Rehabilitation ◽  
Exercise Testing ◽  
Text Messages ◽  
Control Group ◽  
Stand Test ◽  
Randomized Controlled ◽  
Sit To Stand ◽  
Significant Difference

Although the efficacy of cardiac rehabilitation (CR) is proven, the need to improve patients’ adherence has emerged. There are only a few studies that have investigated the effect of sending text messages after a CR period to stimulate subjects’ ongoing engagement in regular physical activity (PA). A randomized controlled pilot trial was conducted after CR, sending a daily PA text message reminder to an intervention group (IG), which was compared with a usual care control group (CG) during three months of follow-up. Thirty-two subjects were assessed pre- and post-study intervention with GPAQ, submaximal iso-watt exercise testing, a 30 s sit-to-stand test, a bilateral arm curl test, and a final survey on a seven-point Likert scale. A statistically significant difference in the increase of moderate PA time (Δ 244.7 (95% CI 189.1, 300.4) minutes, p < 0.001) and in the reduction of sedentary behavior time (Δ −77.5 (95% CI 104.9, −50.1) minutes, p = 0.004) was shown when the IG was compared with the CG. This was associated with an improvement in heart rate, blood pressure, and patients’ Borg rating on the category ratio scale 10 (CR10) in iso-watt exercise testing (all p < 0.05). Furthermore, only the IG did not show a worsening of the strength parameters in the follow-up leading to a change of the 30 s sit-to-stand test with a difference of +2.2 (95% CI 1.23, 3.17) repetitions compared to CG (p = 0.03). The telemedical intervention has been appreciated by the IG, whose willingness to continue with regular PA emerged to be superior compared to the CG. Text messages are an effective and inexpensive adjuvant after phase 2 CR that improves adherence to regular PA. Further studies are needed to confirm these results in a larger patient population and in the long term.

scholarly journals Effectiveness of Abdominal and Gluteus Medius Training in Lumbo-Pelvic Stability and Adductor Strength in Female Soccer Players. A Randomized Controlled Study

2021 ◽  
Vol 18 (4) ◽  
pp. 1528
Author(s):  
Héctor Guerrero-Tapia ◽  
Rodrigo Martín-Baeza ◽  
Rubén Cuesta-Barriuso
Keyword(s):  
Repeated Measures ◽  
Gluteus Medius ◽  
Soccer Players ◽  
Controlled Study ◽  
Control Group ◽  
Extrinsic Factors ◽  
Randomized Controlled ◽  
Limb Injuries ◽  
Experimental Group

Background. Abdominal and lumbo-pelvic stability alterations may be the origin of lower limb injuries, such as adductor pathology in soccer players. Imbalance can be caused by both intrinsic and extrinsic factors. Methods: In this randomized controlled trial over 8 weeks, 25 female footballers were randomly allocated to an experimental group (isometric abdominal training and gluteus medius-specific training) or a control group (isometric abdominal training). Evaluations were performed at baseline, at the end of the intervention and after a 4-week follow-up period. The exercise protocol in common for both groups included three exercises: Plank, Lateral plank and Bird dog. Specific exercises for the gluteus medius were: Pelvic drop and Stabilization of the gluteus medius in knee valgus. Outcome measures were lumbar-pelvic stability and adductor strength. Results: After the intervention, there was an increase in lumbo-pelvic stability in both groups, being greater in the control group than in the experimental group (mean differences [MD]: 4.84 vs. MD: 9.58; p < 0.01) with differences in the analysis of repeated measures (p < 0.001), but not in group interaction (p = 0.26). Changes were found in adductor strength in the experimental group (MD: −2.48; p < 0.001 in the left adductor; MD: −1.48; p < 0.01 in right adductor) and control group (MD: −1.68; p < 0.001 in the left adductor; MD: −2.05; p < 0.001 in the right adductor) after the intervention, with differences in the analysis of repeated measures in left (p < 0.001) and right (p < 0.001) adductor strength. Conclusions: An abdominal and gluteal training protocol shows no advantage over a protocol of abdominal training alone for lumbo-pelvic stability and adductor strength, while improvements in both variables are maintained at four weeks follow-up.

scholarly journals Efficacy of Mobile phone use on adherence to Nevirapine prophylaxis and retention in care among the HIV-exposed infants in prevention of mother to child transmission of HIV: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Lilian M. N. Kebaya ◽  
Dalton Wamalwa ◽  
Nyambura Kariuki ◽  
Bashir Admani ◽  
Philip Ayieko ◽  
...  
Keyword(s):  
Mobile Phone ◽  
Infant Feeding ◽  
Retention In Care ◽  
Control Group ◽  
Hiv Exposed Infants ◽  
Randomized Controlled ◽  
Phone Calls ◽  
Hiv Exposed ◽  
To Receive

Abstract Background HIV is a major contributor to infant mortality. A significant gap remains between the uptake of infant and maternal antiretroviral regimens and only a minority of HIV-exposed infants receives prophylaxis and safe infant feeding. Losses to follow-up of HIV-exposed infants are associated with shortcomings of facility-based PMTCT models with weak community support of linkages. Use of mobile phones offers an opportunity for improving care and promoting retention assessed by timely attendance of scheduled appointments for the mother-baby pairs and achievement of an HIV-free generation. The objective of this study was to compare self-reported adherence to infant Nevirapine (NVP) prophylaxis and retention in care assessed by timely attendance of scheduled appointments over 10 weeks in HIV exposed infants randomized to 2-weekly mobile phone calls (intervention) versus no phone calls (control). Methods In this open label randomized controlled study, one hundred and fifty HIV infected women drawn from 3 health facilities in Western Kenya and their infants were randomly assigned to receive either phone-based reminders on PMTCT messages or standard health care messages (no calls) within 24 h of delivery. Women in the intervention arm continued to receive fortnightly phone calls. At 6- and 10-weeks following randomization we collected data on infant adherence to Nevirapine, mode of infant feeding, early HIV testing and retention in care in both study arms. All analyses were intention to treat. Results At 6 weeks follow-up, 90.7% (n = 68) of participants receiving phone calls reported adherence to infant NVP prophylaxis, compared with 72% (n = 54) of participants in the control group (p = 0.005). Participants in the intervention arm were also significantly more likely to remain in care than participants in the control group [78.7% (n = 59) vs. 58.7% (n = 44), p = 0.009 at 6 weeks and 69.3% (n = 52) vs. 37.3% (n = 28), p < 0.001 at 10 weeks]. Conclusions These results suggest that phone calls are potentially an important tool to improve adherence to infant NVP prophylaxis and retention in care for HIV-exposed infants. Trial registration PACTR202007654729602. Registered 6 June 2018 - Retrospectively registered, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3449

scholarly journals Short-term balance training and acute effects on postural sway in balance-deficient older adults: a randomized controlled trial

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Niklas Sörlén ◽  
Andreas Hult ◽  
Peter Nordström ◽  
Anna Nordström ◽  
Jonas Johansson
Keyword(s):  
Older Adults ◽  
Postural Sway ◽  
Intervention Group ◽  
Community Dwelling ◽  
Control Group ◽  
Positive Effects ◽  
Randomized Controlled ◽  
Eyes Closed ◽  
Balance Exercise

Abstract Background We aimed to determine the effectiveness of 4 weeks of balance exercise compared with no intervention on objectively measured postural sway. Methods This was a single-center parallel randomized controlled, open label, trial. A six-sided dice was used for allocation at a 1:1-ratio between exercise and control. The trial was performed at a university hospital clinic in Sweden and recruited community-dwelling older adults with documented postural instability. The intervention consisted of progressively challenging balance exercise three times per week, during 4 weeks, with follow-up at week five. Main outcome measures were objective postural sway length during eyes open and eyes closed conditions. Results Sixty-five participants aged 70 years (balance exercise n = 32; no intervention n = 33) were randomized. 14 participants were excluded from analysis because of early dropout before follow-up at week five, leaving 51 (n = 22; n = 29) participants for analysis. No significant differences were detected between the groups in any of the postural sway outcomes. Within-group analyses showed significant improvements in hand grip strength for the intervention group, while Timed Up & Go improvements were comparable between groups but only statistically significant in the control group. Conclusions Performing balance exercise over a four-week intervention period did not acutely improve postural sway in balance-deficient older adults. The lower limit in duration and frequency to achieve positive effects remains unclear. Trial registration Clinical trials NCT03227666, July 24, 2017, retrospectively registered.

Effects of Aerobic, Resistance, or Combined Exercise Training Among Older Adults with Subjective Memory Complaints: A Randomized Controlled Trial

2021 ◽  
pp. 1-17
Author(s):  
Taeko Makino ◽  
Hiroyuki Umegaki ◽  
Masahiko Ando ◽  
Xian Wu Cheng ◽  
Koji Ishida ◽  
...  
Keyword(s):  
Older Adults ◽  
Exercise Training ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Control Group ◽  
Subjective Memory ◽  
Logical Memory ◽  
Randomized Controlled ◽  
Community Dwelling Older Adults

Background: Physical exercise is suggested to be effective for preventing cognitive decline in older adults, but the relative efficacy of different types of exercise have yet to be clarified. Objective: This single-blinded randomized controlled trial was designed to investigate the differential effects of aerobic exercise training (AT), resistance exercise training (RT), and combined exercise training (CT) on cognition in older adults with subjective memory complaints (SMC). Methods: Community-dwelling older adults with SMC (n = 415; mean age = 72.3 years old) were randomly assigned to one of the four groups: AT, RT, CT, or control group. The study consisted of two phases: a 26-week intervention and a 26-week follow-up. The participants were evaluated at baseline, 26 weeks (postintervention), and 52 weeks (follow-up). The primary outcome of this study was memory function, which was assessed using the Logical Memory II subtest of the Wechsler Memory Scale-Revised (WMS-R) score. The secondary outcomes included global cognitive function, verbal fluency, working memory, processing speed, and executive functions. Results: Intention-to-treat analysis by a mixed-effect model repeated measure showed that the AT group had significantly improved performance on the WMS-R Logical Memory II test (2.74 [1.82–3.66] points) than the control group (1.36 [0.44–2.28] points) at the postintervention assessment (p = 0.037). The effect was more pronounced in those without amnesia than those with amnesia. No significant improvement was observed in the RT and CT groups. Conclusion: This study suggests that AT intervention can improve delayed memory in community-dwelling older adults, particularly in individuals without objective memory decline.

scholarly journals Effect of physician prescribed information on hospital readmission and death after discharge among patients with health failure: A randomized controlled trial

2021 ◽  
Vol 27 (1) ◽  
pp. 146045822199640
Author(s):  
Faranak Kazemi Majd ◽  
Vahideh Zarea Gavgani ◽  
Ali Golmohammadi ◽  
Ali Jafari-Khounigh
Keyword(s):  
Randomized Controlled Trial ◽  
Hospital Readmission ◽  
Medical Information ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Long Term Follow Up ◽  
Oral Information

In order to understand if a physician prescribed medical information changes, the number of hospital readmission, and death among the heart failure patients. A 12-month randomized controlled trial was conducted (December 2013–2014). Totally, 120 patients were randomly allocated into two groups of intervention ( n = 60) and control ( n = 60). Accordingly, the control group was given the routine oral information by the nurse or physician, and the intervention group received the Information Prescription (IP) prescribed by the physician as well as the routine oral information. The data was collected via telephone interviews with the follow-up intervals of 6 and 12 months, and also for 1 year after the discharge. The patients with the median age of (IQR) 69.5 years old (19.8) death upon adjusting a Cox survival model, [RR = 0.67, 95%CI: 0.46–0.97]. Few patients died during 1 year in the intervention group compared to the controls (7 vs 15) [RR = 0.47, 95%CI: 0.20–1.06]. During a period of 6-month follow-up there was not statistically significant on death and readmission between two groups. Physician prescribed information was clinically and statistically effective on the reduction of death and hospital readmission rates among the HF patients in long term follow-up.

scholarly journals Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

Structured Counselling and Regular Telephonic Follow Up among Diabetic Retinopathy Patients to improve Timely Referral Flow and Compliance from peripheral eye care centre to tertiary centre in Nepal: A Randomised Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Binita Bhattarai ◽  
Saraswati Khadka, Thapa ◽  
Hari Bahadur Thapa ◽  
Sandip Bashyal ◽  
Bhesh Bikram Thapa, Chhetri ◽  
...  
Keyword(s):  
Diabetic Retinopathy ◽  
Controlled Trial ◽  
Treatment Options ◽  
Control Group ◽  
Intervention Package ◽  
Referral Centre ◽  
Randomized Controlled ◽  
Referral Compliance ◽  
Timely Referral

BACKGROUND Diabetic Retinopathy (DR) is an emerging public health issue. DR may lead to severe visual impairment or blindness. Referral communication and tracking system is helpful to monitor patients flow, timeliness and compliance; ensures a close relationship across health facilities and improves patient’s satisfaction. The aim of the study is to improve timely referral flow and compliance of patients diagnosed with DR. OBJECTIVE Primary objective: To assess the effect of intervention on timely referral compliance Secondary objectives: To assess the determinants and cost effectiveness of the intervention for timely referral compliance. METHODS This is an operational research study using cluster randomized controlled health facility-based trial. A situational analysis was conducted and problem tree was developed to identify different barriers to referral compliance (long waiting time, lack of knowledge about diabetic retinopathy, its impact on vision and different treatment options).Appropriate solutions were identified through comprehensive literature review and addressing individual barriers to improve poor referral and compliance of patients diagnosed with DR from peripheral centres (referring centre). These solutions were systemically arranged in the form of an intervention package, which will be tested using a cluster-based randomized controlled trial. Ten eligible peripheral hospitals out of 19will be randomly selected and allocated (lottery method); five each in intervention and control groups. Structured counselling and referral communication linkage will be implemented to the intervention group. Structured counselling, health educational material, and telephonic follow-up will be provided by a trained counsellor at the referring centre; patients will be told in detail about DR, its impact on eyes and vision, treatment options available and the treatment cost for different procedures. They will be explained process at LEIRC (referral centre) and a contact person shall facilitate their treatment at the referral centre. Patients in Control group will receive ongoing routine counselling and health education material. We collected data on referral and compliance, and their determinants using referral-and DR-registers, and structured questionnaires for 1.demographic and socioeconomic profile of patients, 2.telephonicfollow-up with noncompliant patients,3.Feedback of those referred, and 4.Performa for clinical information. Compliance is considered when the referred participant reports at referral centre within one month of counselling. Referral compliance between the two groups will be compared using appropriate statistical tests. Adjusted analysis will be conducted. RESULTS Due to COVID-19 pandemic the inflow of patients is reduced, thus the duration of the data collection will be increased. In the first 6 months of pilot data collection73 in intervention and 34 in control group were screened for referral; 12(21.82%) and 15(27,2%) already had severe NPDR or PDR at the time of screening. CONCLUSIONS Early stage of DR is asymptomatic and can go unnoticed until it affects vision leading to visual impairment and blindness. This study will assess the feasibility and effectiveness of a referral intervention package for improving early diagnosis and treatment with preservation of vision among DR patients. CLINICALTRIAL Clinicaltrials.gov NCT 04834648

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